Basics of Equipment Qualification - 2

Installation Qualification to be re-qualified in case of:
1. Shifting of the equipment from one location to another (excluding portable

type).
2. In case of major modification or to address the qualification of newly added
component
IQ is to be executed typically against a pre-approved protocol, and all the results are to be
compiled and summarized.
Operational Qualification
 OQ specifically tests each function of the system e.g., unit operational
functions, specific equipment functional testing, etc.
 To ensure that the intended tasks will be performed when the system is
adjusted and operated throughout the recommended operating ranges.
 The OQ execution process provides an assessment of the system operation.
 The OQ phase includes calibration/testing of the instruments.
 For instruments such as dial type gauges, load cells, etc., where there is
possibility of malfunctioning due to improper
installation/transportation calibrated at site during OQ.
 The IQ protocols have a provision to identify such instruments, which requires
calibration.
 The other goal of OQ is to confirm that the system can sequence through its
operating steps, and that key process parameters or functions are checked, to
ensure that they are in compliance with the operating specifications. Once the
results of the IQ execution have been reviewed and approved, the OQ
execution can begin.
 During OQ, if any calibration activities are undertaken by an external agency,
the calibration reports of such activity reviewed by site representative for
compliance to laid down specifications.
 Such external agency reports/ data from the part of calibration data and
qualification report.
 Any change(s) made to the system/equipment during the OQ documented in
the OQ report. Any changes proposed after the OQ (During PQ or routine
manufacturing) managed through change control SOP.
 A draft Standard Operating Procedure for operation & preventive maintenance
(wherever applicable) of the equipment, instrument & system prepared
before/during the Operational Qualification. The draft Standard Operating
Procedure for operation approved and effective before the performance
qualification is initiated.
Operational Qualification to be re-qualified incase of:
 Shifting of the equipment from one location to another (excluding portable

type).
 In case of major modification or to address the qualification of newly added
component RQ be initiated (RQ is referred in a separate section).
OQ is executed against a pre-approved protocol, and all the results are to be compiled and
summarized.
Performance Qualification
The PQ integrates procedures, personnel, systems, and materials to verify that the
pharmaceutical grade utility, environment, equipment, or support system produces the
required output. This output may be Product or product contact utility (clean compressed
air, Purified water, etc.) or environment (HVAC system).
The testing philosophy, during designing of protocols, are governed by following

principles, and explanations enumerated here under,
 Each system, and equipments in particular have many variables, and they have
relationship w.r.t. to equipment, process (unit operation) and formulation /
Product. This relationship that can be strong to weak, or not applicable from
the basis for PQ verification steps.
 Variables related to equipment investigated during PQ as specific tests or Load
Trials as designed in the protocol.
 The process measures, which are actually dependent on the formulation
characteristics, and combination of interactions of process and formula, tested
as a part of process validation exercise. For example achieving of Blend
Uniformity (BU) of Blend in Qualification of the Blender is more a process
and type of formulation variables having strong relation to process and
formula.
 Further as applicable, capacity and occupancy also determined to cover edge
failure cases.
 All equipments coming in to direct contact with product(process steps and
primary packing), can contribute adversely, if cleaning procedures are not
adequate, hence during PQ, the fundamental elements of base line data,
required for Cleaning Validation program, like Total Contact surface
area, established. Also equipment cleaned as per the SOP, and
verification done, for cleanliness by visual criteria. This ensures that basic,
elements verification during PQ, and builds a “Procedures to obtain base
line/input data, for the cleaning validations program matrix.
Pre-requisites to PQ execution are:
 Availability of approved OQ Report

 Availability of effective SOPs for operation, calibration, cleaning,
maintenance of the said equipment
 Training of relevant personnel
 Updation of Calibration & PM Schedules
 Completion of PLC Validation
 Training on GDP for external vendor, if vendor is executing the protocol
Acceptance criteria should be clearly indicated within the PQ document.
The PQ is the final stage of qualification, which demonstrates how equipment/system

will perform under simulated or actual production or operating conditions. This series of
tests is designed to demonstrate that the equipment/system is capable of consistently
operating and manufacturing product of specified quality in the worst case. This phase
can only be undertaken once the operating parameters have been defined and approved.
Performance Qualification to be re-qualified in case of:

1. Replacement of existing instrument / component in the equipment with a new
one, which can have a direct impact on the performance of the equipment.
2. Any major modification to the existing Equipment/System, which can affect
the performance of the equipment.
3. If system is found to be malfunctioning during performance qualification.
PQ executed in a pre-approved protocol
Re-Qualification
Re-Qualification is an activity involving complete or portions of ‘elements’ of
qualification activities, like IQ, OQ and PQ.
Re-Qualification carried out for one or more of the following reasons:
 To address deficiencies observed in an executed qualification

 Need for additions in qualification test criteria
 To qualify changes done in the equipment or a process involving the
equipment
 Failure
 CAPA
 Findings/Recommendations from Inspections/Audits/ PQR, etc.
 Inputs from Preventive Maintenance/Calibration Program
 Equipment Up-gradation
In addition to testing the elements impacted by the changes or qualification parameters

found to be deficient, all critical components of the equipment verified for functionality
during Re-Qualification.

Basics of Equipment Qualification - 2

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Installation Qualification to be re-qualified in case of:

1. Shifting of the equipment from one location to another (excluding portable

Operational Qualification to be re-qualified incase of:

 Shifting of the equipment from one location to another (excluding portable

The testing philosophy, during designing of protocols, are governed by following

Pre-requisites to PQ execution are:

 Availability of approved OQ Report

Acceptance criteria should be clearly indicated within the PQ document.

The PQ is the final stage of qualification, which demonstrates how equipment/system

Performance Qualification to be re-qualified in case of:

PQ executed in a pre-approved protocol

Re-Qualification carried out for one or more of the following reasons:

 To address deficiencies observed in an executed qualification

In addition to testing the elements impacted by the changes or qualification parameters

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